Shoulder PainNCT04538690
The Effect of Exercise Therapy in Painful Shoulder Disorders
A study testing Shoulder Exercises and Electrotherapy in people with Shoulder Pain and Shoulder Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Shoulder Pain, Shoulder Disease, Balance; Distorted
- What is being tested?
- Shoulder Exercises and Electrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2020to 20 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having one of the diagnoses of impingement, rotator cuff syndrome, frozen shoulder, biceps tendon,
- Pain severity felt by the patient above-8 according to the Visual Analogue Scale divided into 10 equal intervals,
- Patients who were recommended conservative treatment
Who cannot join
- Any previous surgical operation,
- Skeletal system fractures or dislocations,
- Other diagnosed orthopedic, neurological or rheumatological diseases, diabetes, neuropathy and pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul, Beykoz, 34815
Gizem Ergezen, MSc, 4448544 ext. 2520, gergezen@hotmail.com
Gizem Ergezen, MSc
About this study
Official title: The Effect of Exercise Therapy on Balance and Pain in Painful Shoulder Disorders
20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. Our hypothesis is that the balance will improve and pain will decrease in individuals after exercise.
Read the detailed description
20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. Exercises will be applied 3 days a week for 4 weeks, 45-55 minutes by a physiotherapist within the framework of shoulder rehabilitation. In addition, balance exercises will not be given. Balance measurements will be made by the Biodex Balance System, which provides objective data.
- Conditions
- Shoulder Pain, Shoulder Disease, Balance; Distorted, Exercise
- Being tested
- Shoulder Exercises, Electrotherapy
- Medical subject headings
- Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder ExercisesOther
Exercises consist of shoulder range of motion, releasing exercises, strength training, stretching.
ElectrotherapyOther
TENS, US
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Age and sex matched non interventional, healthy control group |
| Exercise Group | Experimental | Individuals who are taken part of shoulder exercises with painful shoulder disorders. Receives: Other: Shoulder Exercises; Other: Electrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Balance Measurement
By Biodex Balance System Stability and Fall Risk, static and dynamic
Measured: 4 week
Pain Intensity
By Visual Analogue Scale scored between 0-10. 0 means no pain and 10 means unbearable pain.
Measured: 4 week
Secondary outcomes (1)
Range of Motion
By Goniometer shoulder range of motion will be measured
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start15 Sep 2020
- Primary completion15 Nov 2020 (estimated)
- Study completion20 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem ergezen, Medipol University
- Investigators
- Gizem Ergezen, MSc, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538690
- Sponsor's protocol ID
- 10840098-722.02
- Status last verified
- Oct 2020
- First submitted
- 31 Aug 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Therapy on Balance and Pain in Painful Shoulder Disorders
- ClinicalTrials.gov ID
- NCT04538690
- Acronym / sponsor ID
- 10840098-722.02
- Conditions
- Shoulder Pain, Shoulder Disease, Balance; Distorted, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 20 Nov 2020 (estimated)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. Our hypothesis is that the balance will improve and pain will decrease in individuals after exercise.
Detailed description
20 adults who applied to the orthopedic clinic with shoulder pain, did not require surgical intervention, were referred to the physiotherapy clinic for treatment; will be evaluated in terms of balance, pain and joint range of motion and then included in the exercise program. 20 adults without pain will be evaluated as the control group and the results will be compared within and between groups. Exercises will be applied 3 days a week for 4 weeks, 45-55 minutes by a physiotherapist within the framework of shoulder rehabilitation. In addition, balance exercises will not be given. Balance measurements will be made by the Biodex Balance System, which provides objective data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Age and sex matched non interventional, healthy control group |
| Exercise Group | Experimental | Other: Shoulder Exercises, Other: ElectrotherapyIndividuals who are taken part of shoulder exercises with painful shoulder disorders. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having one of the diagnoses of impingement, rotator cuff syndrome, frozen shoulder, biceps tendon,
- Pain severity felt by the patient above-8 according to the Visual Analogue Scale divided into 10 equal intervals,
- Patients who were recommended conservative treatment
Key exclusion criteria (3 listed)
- Any previous surgical operation,
- Skeletal system fractures or dislocations,
- Other diagnosed orthopedic, neurological or rheumatological diseases, diabetes, neuropathy and pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder ExercisesExercises consist of shoulder range of motion, releasing exercises, strength training, stretching. | Other | Exercise Group |
| ElectrotherapyTENS, US | Other | Exercise Group |
Primary outcome
Objective Balance Measurement
Time frame: 4 week
By Biodex Balance System Stability and Fall Risk, static and dynamic
Pain Intensity
Time frame: 4 week
By Visual Analogue Scale scored between 0-10. 0 means no pain and 10 means unbearable pain.
1 secondary outcome
Range of Motion
Time frame: 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
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Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Ergezen, MSc principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder Exercises and Electrotherapy in people with Shoulder Pain and Shoulder Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gizem Ergezen (+905347098414, gergezen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Balance Measurement (time frame: 4 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.